4. Changes and cancellations imposed by HSE

Where an issue with the safety or efficacy of a product is identified, the Health and Safety Executive (HSE) may need to impose amendments to the authorisation or cancel it.

HSE can amend or cancel an authorisation at any time if we consider that:

  • the authorisation was granted based on false or misleading information
  • the conditions are not satisfied in: 
    • Article 19 - for example, the product is sufficiently effective and has no unacceptable effects on humans, animals or the environment
    • Article 25, where relevant - for example, the product is sufficiently effective and does not contain any substances of concern
  • the authorisation holder has failed to comply with its obligations under the authorisation or the law

If HSE intends to cancel or amend an authorisation, we will notify the applicant and give them the opportunity to submit comments or additional information within a specific time frame. We will consider any additional information that has been submitted when finalising our decision. We will inform the authorisation holder of the final decision and any action they may need to take as a result.

 
Updated 2021-07-19